Table 2 Adverse events related to drug administration upon investigator’s report
System organ disorder | All Grades | Grade 1/2 | Grade 3/4 |
|---|---|---|---|
No. (%) | No. (%) | No. (%) | |
Gastrointestinal disorders | |||
Diarrhoea | 6 (35.3%) | 6 (35.3%) | 0 |
Nausea | 8 (47.1%) | 8 (47.1%) | 0 |
Vomiting | 4 (23.5%) | 4 (23.5%) | 0 |
Abdominal pain | 3 (17.6%) | 3 (17.6%) | 0 |
Constipation | 3 (17.6%) | 3 (17.6%) | 0 |
General disorders | |||
Asthenia | 4 (23.5%) | 4 (23.5%) | 0 |
Decreasing appetite | 4 (23.5%) | 4 (23.5%) | 0 |
Vascular disorders | |||
Hypertension | 1 (5.9%) | 0 | 1 (5.9%) |
Hypotension | 1 (5.9%) | 1 (5.9%) | 0 |
Immune system disorders | |||
Infection | 2 (11.8%) | 1 (5.9%) | 1 (5.9%) |
Skin and subcutaneous tissue disorders | |||
Stomatitis | 2 (11.8%) | 2 (11.8%) | 0 |
Hand and foot syndrome | 1 (5.9%) | 1 (5.9%) | 0 |
Blood and lymphatic system disorders | |||
Anaemia | 6 (35.3%) | 6 (35.3%) | 0 |
Neutropenia | 4 (23.5%) | 1 (5.9%) | 3 (17.6%) |
Thrombopenia | 6 (35.3%) | 6 (35.3%) | 0 |
Liver function test disorders | |||
Gamma GT increased | 2 (11.8%) | 2 (11.8%) | 0 |
Alanine aminotransferase increased | 1 (5.9%) | 1 (5.9%) | 0 |
PAL increased | 4 (23.5%) | 4 (23.5%) | 0 |
Aspartate aminotransferase increased | 1 (5.9%) | 1 (5.9%) | 0 |
Hyperbilirubinemia | 2 (11.8%) | 2 (11.8%) | 0 |
Neuromuscular disorders | |||
Myalgia | 2 (11.8%) | 2 (11.8%) | 0 |
